Benzonatate
- Product NDC
- 65162-537
- 11-digit product format
- 651620537
- Labeler code
- 65162
- Product ID
- 65162-537_72b0f799-3f8f-4dcf-9c6e-57e796996a80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA040682
- Marketing category
- ANDA
- Marketing start
- 2010-06-04
- Substance
- BENZONATATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benzonatate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZONATATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5P4DHS6ENR |
| Rxcui | 197397, 283417 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-537-10 | Benzonatate | 100 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 100 | | 17 |
| 65162-537-50 | Benzonatate | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-537 | BENZONATATE CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC] | 17 | Current NDC, Legacy NDC, 2 package rows | 20241025_199a42ae-4d19-4e68-934d-dabd27084988.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-537-10 | 65162053710 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-537-10) | 2010-06-04 | 0000-00-00 | No | No | Current |
| 65162-537-50 | 65162053750 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-537-50) | 2010-06-04 | 0000-00-00 | No | No | Current |